https://apps.elearning.uq.edu.au/wordstream/29271
| Date | History |
|---|---|
| 1937 | Pharmacist kills 107 people with manufactured anaesthetic |
| 1938 | US Food and Drug Administration (FDA) requires manufacturers to demonstrate safety |
| 1960 | FDA rejects new drug submission for Thalidomide |
| 1962 | FDA requires safety and efficacy |
| 2004 | Rofecoxib voluntarily withdrawn |
| Phases | Population | Purpose | Success Rate |
|---|---|---|---|
| Pre-clinical | Animal studies | Assess safety/activity | 5000 |
| Phase I | 20–80 volunteers | Safety and dose | |
| Phase II | 100-300 patients | Proof of concept | 5 |
| Phase III | 1000–3000 patients | Confirm efficacy | |
| FDA | Review process | 1 | |
| Phase IV | Routine use | Post-marketing surveillance |
Which ethical theories were employed to justify Covid-19 response policies?
Which ethical theory provides the best support for pharmacist codes of ethics?
Is it appropriate for pharmacists to refuse to supply emergency contraception?
What are the arguments for and against voluntary assisted dying?
What does it mean to be socially accountable?
Engagement task #2